NL-OMON52660RecruitingNot Applicable
Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study - CBAS180 de-escalation study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pentax Medical
- Enrollment
- 122
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1) Flat type BE esophagus, with an indication for ablation therapy, defined as:
- •a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
- •b) Residual BE with any grade of dysplasia after endoscopic resection (by means
- •of EMR or ESD) to treat non-flat BE, >=6 weeks prior to enrolling the patient to
- •this study. The ER pathology should indicate endoscopic treatment (i.e. only
- •mucosal invasion or limited submucosal invasion (sm1), no lymphovascular
- •infiltration, free vertical resection margins and not poorly differentiated).
- •2) Prague Classification Score of C<=3 and M>=1.
- •3) Patients should be ablation-naïve, meaning they have not undergone any
- •previous endoscopic ablation therapy of the esophagus.
- •4) Older than 18 years of age at time of consent.
- •5) Fit for endoscopic therapy per institution*s standards.
- •6) Provides written informed consent on the IRB-approved informed consent form.
- •7) Willing and able to comply with follow-up requirements.
Exclusion Criteria
- •1) Esophageal stenosis preventing advancement of a therapeutic endoscope.
- •2) Any endoscopically visualized lesion such as ulcers, masses or nodules.
- •Neoplastic nodules must first be treated with ER >=6 weeks prior to planned
- •treatment under this protocol.
- •3) Prior ER of >2cm in length and/or >50% of the esophageal lumen
- •circumference.
- •4) History of locally advanced (>sm1) esophageal cancer.
- •5) History of esophageal varices.
- •6) Prior distal esophagectomy.
- •7) Active esophagitis LA grade B or higher.
- •8) Severe medical comorbidities precluding endoscopy.
- •9) Uncontrolled coagulopathy.
- •10) Pregnant or planning to become pregnant during period of study.
Investigators
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